Recruiting
Phase 3

Lumateperone

Sponsor:

Intra-Cellular Therapies, Inc.

Code:

NCT06229210

Conditions

Schizophrenia

Bipolar Disorder

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Lumateperone

Study Details

Brief summary:

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

Conditions

Schizophrenia

Bipolar Disorder

Autism Spectrum Disorder

Study ID

NCT06229210

Start date

Jan 25, 2024

Status verified date

Aug, 2026

Completion date

Apr 28, 2032

Anticipated

Primary completion date

Apr 28, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to provide consent as follows:

  • The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;
  • The patient must provide written assent to study enrollment;
  • Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
  • Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.

Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.

Exclusion Criteria:

  • Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:

  • ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
  • For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.
  • In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or

  • At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
  • At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
  • At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or
  • The patient is considered to be an imminent danger to him/herself or others.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lumateperone

Interventions

Lumateperone

Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

Primary outcome measure

  • Incidence of Common Adverse Events [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Southwest Autism Research and Resource Center

Recruiting

Phoenix, Arizona, United States, 85006

Pillar Clinical Research, LLC

Recruiting

Little Rock, Arkansas, United States, 72204

Advanced Research Center, Inc

Recruiting

Anaheim, California, United States, 92805

National Institute Of Clinical Research

Recruiting

Garden Grove, California, United States, 92844

Excell Research Inc

Recruiting

Oceanside, California, United States, 92056

Inland Psychiatric Medical Group Inc

Recruiting

Redlands, California, United States, 92373

University Of California - Davis

Recruiting

Sacramento, California, United States, 95817

Next Level Clinical Trials, LLC

Recruiting

West Covina, California, United States, 91790

Sarkis Clinical Trials

Recruiting

Gainesville, Florida, United States, 32607

United Research Institute

Recruiting

Hialeah, Florida, United States, 33012

Advanced Research Institute of Miami

Recruiting

Homestead, Florida, United States, 33033

Green Leaf Clinical Trials

Recruiting

Jacksonville, Florida, United States, 32258

Columbus Clinical Services LLC

Recruiting

Miami, Florida, United States, 33125

Care Research Center Inc

Recruiting

Miami, Florida, United States, 33130

Blue Medical Research

Recruiting

Miami, Florida, United States, 33144

Envision Trials LLC

Recruiting

Miami, Florida, United States, 33166

Diverse Clinical Research LLC

Recruiting

Miami, Florida, United States, 33175

Links Clinical Trials

Recruiting

Miami, Florida, United States, 33176

New Med Research Inc

Recruiting

Miami Gardens, Florida, United States, 33056

The Angel Medical Research Corporation

Recruiting

Miami Gardens, Florida, United States, 33169

Riveldi Biomedical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Clinical Research Center of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

University of South Florida Rothman Center of Neuropsychiatry

Recruiting

St. Petersburg, Florida, United States, 33701

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

CenExeli Research LLC

Recruiting

Atlanta, Georgia, United States, 30030

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

CenExeli Research LLC 1

Recruiting

Savannah, Georgia, United States, 31405

Baber Research Group

Recruiting

Naperville, Illinois, United States, 60563

Neurobehavioral Medicine Group

Recruiting

Bloomfield Hills, Michigan, United States, 48302

Midwest Research Group 1

Recruiting

Saint Charles, Missouri, United States, 63304

Alivation Research LLC

Recruiting

Lincoln, Nebraska, United States, 68526

Clinical Research of Southern Nevada, LLC

Recruiting

Las Vegas, Nevada, United States, 89128

NYU Child Study Center

Recruiting

New York, New York, United States, 10016

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Charak Center for Health and Wellness

Recruiting

Garfield Heights, Ohio, United States, 44125

Sooner Clinical Research

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Access Clinical Trials

Recruiting

Nashville, Tennessee, United States, 37203

Texas Research Group

Recruiting

Coppell, Texas, United States, 75019

PsyMed Solutions

Recruiting

Fort Worth, Texas, United States, 76132

Kaleidoscope Clinical Research

Recruiting

Houston, Texas, United States, 77089

Red Oak Psychiatry Associates

Recruiting

Houston, Texas, United States, 77090

AIM Trials

Recruiting

Plano, Texas, United States, 75093

Perceptive Pharma Research

Recruiting

Richmond, Texas, United States, 77407

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23220

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Core Clinical Research

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Intra-Cellular Therapies, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Intra-Cellular Therapies, Inc. on 2026-08-28.